510(k) K851327

DESERET ARTERIAL CATHETER by Parke-Davis Co. — Product Code FOZ

K851327 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DESERET ARTERIAL CATHETER". The FDA issued a decision of Substantially Equivalent on June 14, 1985. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1985
Date Received
April 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type